Patient comfort apparatus and system

ABSTRACT

Apparatus and a system for thermally comforting a patient include pneumatic, convective providing thermal treatment for persons or animals, which is adapted for use in combination with a clinical garment such as a hospital gown, robe, bib, and other equivalents. The pneumatic convective device provides convective warming focused or directly primarily on the thorax or body core. The pneumatic convective device includes at least one inlet for being accessed through a clinical garment, a region in distribution with the inlet for distributing a stream of pressurized, thermally treated air, and a permeable member for emitting pressurized, thermally treated air from the distribution region.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 USC § 371 as a United StatesNational Phase application of PCT/US2003/011128, filed Apr. 10, 2003,which claims the benefit of U.S. Provisional Application No. 60/371,314filed Apr. 10, 2002.

This application contains subject matter related to that of U.S. patentapplication Ser. No. 10/411,431, for “FORCED AIR WARMING UNIT”, now U.S.Pat. No. 6,876,884, and U.S. patent application Ser. No. 10/411,865, for“PATIENT COMFORT APPARATUS AND SYSTEM”, now U.S. Pat. No. 7,001,416,both filed concurrently with this application, and to that of U.S.Design Patent Application Ser. No. 29/179,545, filed Apr. 10, 2003, for“FORCED AIR WARMING UNIT”, now U.S. Pat. No. D485,338.

This application further contains subject matter related to the subjectmatter of the following patent applications, all commonly ownedherewith:

Patent Cooperation Treaty (PCT) Application No. PCT/US2005/025355, filedJul. 18, 2005, titled “Perioperative Warming Device”, and published onFeb. 23, 2006 under Publication No. WO 2006/020170;

PCT Application No. PCT/US2005/043968, filed Dec. 6, 2005, titled“Warming Device with Varied Permeability”, and published on Jun. 15,2006 under Publication No. WO 2006/062910;

PCT Application No. PCT/US2005/044214, filed Dec. 6, 2005, titled“Warming Device”, and published on Jun. 15, 2006 under Publication No.WO 2006/063027;

PCT Application No. PCT/US2006/004644, filed Feb. 9, 2006, titled“Warming Device for Perioperative Use”, and published on Aug. 17, 2006under Publication No. WO2006/086587;

PCT Application No. PCT/US2006/041028, filed Oct. 19, 2006, titled“Multifunction Warming Device for Perioperative Use”, and published onApr. 26, 2007 under Publication No. WO 2007/047917;

PCT Application No. PCT/US2007/013073, filed Jun. 1, 2007, titled“Warming Device”, published on Jan. 31, 2008 under Publication No. WO2008/013603;

PCT Application No. PCT/US2008/000141, filed Jan. 4, 2008, titled“Convective Warming Device With a Drape”, published on Jul. 31, 2008under Publication No. WO 2008/091486;

U.S. patent application No. 10/411,865, filed Apr. 10, 2003, titled“Patient Comfort Apparatus and System”, and published on Oct. 16, 2003under Publication No. US 2003/0195596, now U.S. Pat. No. 7,001,416;

U.S. patent application No. 10/895,672, filed Jul. 21, 2004, titled“Perioperative Warming Device”, now abandoned, published on Jan. 20,2005, under Publication No. US 2005/0015127;

U.S. patent application No. 11/005,883, filed Dec. 7, 2004, titled“Warming Device with Varied Permeability”, and published on Jun. 8, 2006under Publication No. US 2006/0122671, now U.S. Pat. No. 7,226,454;

U.S. patent application No. 11/006,491, filed Dec. 7, 2004, titled“Warming Device”, and published on Jun. 8, 2006 under Publication No. US2006/0122672, now U.S. Pat. No. 7,364,584;

U.S. patent application No. 11/057,396, filed Feb. 11, 2005, titled“Perioperative Warming Device”, and published on Aug. 17, 2006 underPublication No. US 2006/0184215, now U.S. Pat. No. 7,276,076;

U.S. patent application No. 11/057,397, filed Feb. 11, 2005, titled“Thermal Blanket for Warming the Limbs”, and published on Aug. 17, 2006under Publication No. US 2006/0184216, now U.S. Pat. No. 7,520,889;

U.S. patent application No. 11/057,403, filed Feb. 11, 2005, titled“Warming Device for Perioperative Use”, and published on Aug. 17, 2006under Publication No. US 2006/0184217;

U.S. patent application No. 11/057,404, filed Feb. 11, 2005, titled“Clinical Garment for Comfort Warming and Prewarming”, and published onAug. 17, 2006 under Publication No. US 2006/0184218, now U.S. Pat. No.7,470,280;

U.S. patent application No. 11/260,706, filed Oct. 27, 2005, titled“Patient Comfort Apparatus and System”, and published on Mar. 9, 2006under Publication No. US 2005/0052853;

U.S. patent application No. 11/363,136, filed Feb. 27, 2006, titled“Forced Air Warming Unit”, and published on Jul. 6, 2006 underPublication No. US 2006/0147320;

U.S. patent application No. 11/492,425, filed Jul. 25, 2006, titled“Warming Device”, and published on Nov. 16, 2006 under Publication No.US 2006/0259104;

U.S. patent application No. 11/583,432, filed Oct. 19, 2006, titled“Multifunction Warming Device for Perioperative Use”, and published onApr. 26, 2007 under Publication No. US 2007/0093882;

U.S. patent application No. 11/583,477, filed Oct. 19, 2006, titled“Multifunction Warming Device with Provision for Being Secured”, andpublished on Apr. 26, 2007 under Publication No. US 2007/0093883;

U.S. patent application No. 11/583,480, filed Oct. 19, 2006, titled“Multifunction Warming Device with Provision for Warming Hands”, andpublished on Apr. 26, 2007 under Publication No. US 2007/0093884;

U.S. patent application No. 11/583,481, filed Oct. 19, 2006, titled“Multifunction Warming Device with an Upper Body Convective Apparatus”,and published on Apr. 26, 2007 under Publication No. US 2007/0093885;

U.S. patent application No. 11/656,777, filed Jan. 23, 2007, titled“Convective Warming Device With a Drape”, and published on Jul. 24, 2008under Publication No. US 2008/0177361;

U.S. patent application No. 11/704,547, filed Feb. 9, 2007, titled “AForced Air Warming Unit”, and published on Aug. 14, 2008 underPublication No. US 2008/0195184;

U.S. patent application No. 11/801,292, filed May 9, 2007, titled“Warming Device with Varied Permeability”, and published on Oct. 11,2007 under Publication No. US 2007/0239239;

U.S. patent application No. 11/899,872, filed Sep. 7, 2007, titled“Perioperative Warming Method”, and published on Jan. 31, 2008 underPublication No. US 2008/0027522;

U.S. patent application No. 11/899,928, filed Sept. 7, 2007, titled“Perioperative Warming Device” and published on Jan. 31, 2008 underPublication No. US 2008/0027521;

U.S. patent application No. 12/011,699, filed Jan. 29, 2008, titled“Warming Device”, published on May 29, 2008 under Publication No. US2008/0125840, and republished on Jun. 11, 2009 under Publication No. US2009/0149931;

U.S. patent application No. 12/290,713, filed Nov. 3, 2008, titled“Clinical Garment for Comfort Warming and Prewarming”, and published onMar. 5, 2009 under Publication No. US 2009/0062891;

U.S. patent application No. 12/386,243, filed Apr. 15, 2009, titledWarming Device with Provisions for Deploying Elements of an Upper BodyConvective Apparatus and for Deploying the Lower Portion of the WarmingDevice, and published on Sep. 10, 2009 under Publication No. US2009/0228083, and

U.S. patent application No. 12/653,825, filed Dec. 21, 2009, titled“Warming Device Constructions with a Poncho-Type Patient Gown”.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention is directed to a patient comfort system that includespneumatic convective devices receivable on a human or animal body whichreceive a stream of pressurized, thermally conditioned air, distributethe pressurized air within a pneumatic structure, and emit the airthrough one or more surfaces for convective transfer of heat between thethermally conditioned air and the body. In particular, the invention isdirected to the warming of human or animal bodies in a clinical settingby measures that adapt pneumatic convective devices for use withclinical garments, thereby providing thermal treatment to wearers ofsuch garments while permitting movement of the user and enhancingclinical convenience.

2. Description of the Related Art

Pneumatic devices which transfer heat between thermally-conditioned airand a body are known. For example, there are inflatable pneumaticdevices that receive a stream of pressurized, warmed air, inflate inresponse to the pressurized air, distribute the warmed air within apneumatic structure, and emit the warmed air onto a body to accomplishsuch objectives as increasing comfort, reducing shivering, and treatingor preventing hypothermia. These inflatable devices are typicallycharacterized as “blankets” or “covers”. Arizant Healthcare Inc., theassignee of this application, makes and sells such devices under theBAIR HUGGER® brand. One such device is the Model 522 Upper Body Blanket.

Inflatable pneumatic warming blanket or cover devices are adaptedespecially for use with supine persons and are typically deployed bybeing laid directly on a person lying on a bed, a gurney, or a surgeryplatform, so as to drape over or cover some portion of the person.Because these devices are designed to cover and hang about or over asupine person, they are not easily or readily deployed on persons whoare standing, sitting, reclining or moving. In particular, inflatableblankets are not suitable in a clinical setting in which it is desirableto warm a patient, and also necessary that the patient be able to moveabout and between various postures. In addition, there are a variety ofclinical settings in which patient warming is desirable, with eachsetting requiring its own unique access to patient anatomy that may notbe afforded by an inflatable blanket. For example, examination ortreatment of a patient in a primary acute care unit (PACU) could callfor access to patient lines in the chest area, setting IV's in the arm,application of a stethoscope to the back and/or side, or application ofa blood pressure cuff. Further, patient mobility throughout a clinic ora hospital is highly desirable, but would be severely curtailed with useof inflatable blankets. For example, transporting a patient to an x-rayor MRI location in a wheelchair, would be made problematic with aninflatable blanket.

There is also an advantage in not changing established and familiaralgorithms of care in which both patients and nurses deal with clinicalgarments, such as gowns, and nurses know how to deliver care in allcircumstances where a patient is wearing a clinical garment. If aninflatable blanket were to be used for warming, a new algorithm would berequired to deal with this new element in clinical practice.

One attempt to adapt an inflatable pneumatic blanket for non-supinepostures is embodied in U.S. Pat. No. 5,697,963, assigned to AugustineMedical, Inc. and incorporated by reference. In this adaptation, aninflatable pneumatic blanket having a head-section drape is providedwith an aperture in the head section drape that is large enough toaccommodate the head of a person sitting in a chair. However, thisadaptation has a limited use in that a person using it must remain in asitting or reclining posture in order for the device to drape over theperson's body and retain warmed air and heat about the person. Suchdevices are not designed to accommodate movement or changes in theperson's posture or to allow easy access to patient anatomy. Thesedevices are meant to treat hypothermia by driving calories into thepatient.

Other inflatable pneumatic warming devices designed for use with supinepersons employ tubular structures to at least partially surround aperson, and utilize sheets of material extending across the person andthe structures to retain warmed air and heat about the person. Thesedevices are even less adaptable than blanket devices for non-supineuses. See, for example, U.S. Pat. Nos. 5,300,101 and 5,674,269, whichare incorporated by reference.

A need exists for a pneumatic convective device that achieves theobjectives of increased comfort, reduced shivering, and treatment orprevention of hypothermia in a clinical or medical office setting wherepatients must be able to change postures and enjoy a certain amount ofmobility without a significant impact on or change to the treatmentalgorithm. For example, when visiting a physician for an examination, apatient may be ushered into an examination room, asked to removeclothing in order to permit examination, and given a thin cloth gown towear while awaiting the physician. In this environment, the patient maybe chilled, may shiver, or may be in a condition conducive tohypothermia. Patient anxiety is frequently exacerbated by this colddiscomfort. Concomitant with a heightened level of anxiety, patientsperceive time as slowing and this anxious waiting period can seem to beprolonged. The cold discomfort can cause a one hour wait to seem like 2hours to the patient. People tend to vasoconstrict when frightened, andvasoconstriction can lead to reduced peripheral temperature andincreased blood pressure, and can make IV access much more difficult.Finally, there is evidence that feeling cold increases the perception ofpain. A thin cloth gown provides little in the way of insulation,warmth, and comfort in such circumstances. Therefore, in addition to thepatient satisfaction and comfort produced by a bath of thermally-treatedair, providing warmth to a cold patient in a medical setting shouldproduce the following unexpected benefits: 1.) reduced blood pressureand easier IV access; 2.) reduced pain sensation; 3.) normalizing of thepatient's perception of time slowing; 4.) reduced anxiety and reducedneed for medication. These and other objectives are realized when apatient is maintained in a state of thermal comfort. In this regard,“thermal comfort” for a person is defined by P. O. Fanger as “thatcondition of mind which expresses satisfaction with the thermalenvironment”. Fanger, Thermal Comfort: Analysis and Applications inEnvironmental Engineering, Danish Technical Press, Copenhagen, 1970.

It would be advantageous to provide a course of action, a method, or aninstrument by which a patient could be maintained in a state of thermalcomfort characterized by a comfortable, healthy temperature whileawaiting the physician and even while undergoing examination ortreatment. An inflatable blanket or cover could be deployed for thispurpose, but would be very impractical because the patient would berequired to remain supine or maintain a prone or sitting position.Clinical convenience and utility dictate a more flexible solution inwhich a pneumatic, convective device serves a warming function in one ormore forms that permit movement of the user and of the device itself onthe user for examination. It would be particularly advantageous if thesolution comported with present modes of treatment that presume the useof clinical garments. For optimal heating, such forms should focus orconcentrate the convective effect on the portion of a body being warmedthat has the highest concentration of cutaneous thermal receptors. Thisportion includes the head, neck, chest and abdomen.

Pneumatic devices that thermally condition persons while standing and/ormoving are known. One such device, described in U.S. Pat. No. 4,457,295incorporates a pneumatic, convective means into an article of clothingthat is intended for heavy-duty use in an unfriendly environment. Theobjective of this device is to warm and ventilate by general applicationof pressurized, heated air through the inside of a closed article ofclothing. The pressurized, heated air is provided through a valve systemfrom a source that is convenient to a particular unfriendly environment,such as an exhaust manifold of a motorcycle engine. The article ofclothing is fitted to the wearer's body and is closed in order to affordprotection against the environment in which the device is deployed.Thus, the device further requires a means for ventilating moisture fromwithin the article of clothing. Its normally closed configuration andcomplicated pneumatics make this device inconvenient and impractical touse for patient comfort in a clinical environment.

A pneumatic garment, described in U.S. Pat. No. 3,468,299, includes ahooded overcoat intended to be used in unfriendly environments forheating and ventilating a person. This device's structure and operationmake it also unsuitable for use in maintaining patient comfort in aclinical environment.

SUMMARY OF THE INVENTION

The invention is based upon the critical realization that garmentspresently available for use on ambulatory patients can be adapted toprovide thermal comfort when combined with a pneumatic convectivedevice. In this regard, lightweight robes or gowns which open at theback or a side, are worn with an open bottom like a skirt or kilt, andare supported primarily at the shoulders and/or neck of the users arereferred to as “clinical garments”. These clinical garments affordmobility for users; they also provide convenience for clinicians duringexamination in that they may be easily moved, adjusted, removed, and putback on. Accordingly, the invention provides pneumatic convectivethermal treatment of the feeling of being cold by means of pneumaticconvective devices adapted for use in combination with clinicalgarments. The invention also includes the combination of a clinicalgarment with a pneumatic convective device, as well as a system andmethod employing such a combination to maintain comfort a patient bywarming. The pneumatic convective devices provide effective convectivewarming that is focused or directed primarily on or to the mostthermally sensitive regions of a user. These devices are also simple tomanufacture, store, and deploy for use. Finally, because this inventionis meant to produce or induce a state of thermal comfort in a patient,without providing hypothermia therapy, airflow exiting the pneumaticconvective device of less than 15 CFM (cubic feet per minute) and atemperature of less than 105° F. are preferred.

BRIEF DESCRIPTION OF THE DRAWING

FIGS. 1A-1G illustrate a pneumatic convective device that is combinedwith a clinical garment according to an embodiment of the invention.FIG. 1H is a perspective view drawing showing engagement of thecombination in a warming system.

FIGS. 2A-2D illustrate an air hose coupling adapted for use with thepneumatic convective device of FIGS. 1A-1H.

FIGS. 3A-3F illustrate a pneumatic convective device that is combinedwith a clinical garment according to another embodiment of theinvention. FIG. 3G is a perspective view drawing showing engagement ofthe pneumatic convective device with an air hose. FIGS. 3H-3K arephotographs showing the pneumatic convective device of FIGS. 3A-3G inuse with a hospital gown.

FIGS. 4A-4C illustrate an air hose coupling adapted for use with thepneumatic, convective device of FIGS. 3A-3G.

FIGS. 5A-5C illustrate complementary adaptations of an end of an airhose and an edge of a pneumatic convective device according to FIG. 3A.

FIGS. 6A-6D illustrate a pneumatic convective device combined with aclinical gown according to yet another embodiment of the invention. FIG.6E is a plan view photograph of the pneumatic convective device of FIG.6A-6D. FIG. 6F is a photograph of the pneumatic convective devicedisposed, uninflated on the shoulders of a user. FIGS. 6G-6I arephotographs showing the pneumatic convective device of FIGS. 6A-6D inuse.

FIGS. 7A-7F illustrate complementary adaptations of an end of an airhose and a stem of a pneumatic convective device according to FIG. 6A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention is embodied as a pneumatic convective device receivable ona human or animal body in a clinical setting which receives a stream ofpressurized, thermally conditioned air, distributes the pressurized airwithin a pneumatic structure, and emits the air through one or moresurfaces for convective transfer of heat between the thermallyconditioned air and the body. The invention is further embodied as apneumatic convective device combined with a clinical garment tothermally comfort a patient in a clinical setting. Various specificembodiments of the invention are illustrated and discussed according toan example in which a human body is warmed by focusing or concentratingconvective warming on the body core in order to permit patient movementand to enhance clinical convenience, although this is not intended tosuggest that the invention may not be used for cooling, which, indeed,it may.

Further, use of the term “convective” to denote the transfer of heat toa body refers to the principal mode of heat transfer, it beingunderstood that heat may at the same time be transferred between adevice according to this invention and a body by conduction andradiation, although not to the degree of convection.

A pneumatic convective device is adapted for use with a clinical garmentthat is typically used to temporarily clothe a person in a clinicalsetting while awaiting and undergoing treatment. Clinical garmentsinclude hospital gowns, robes, bibs, and other equivalents. The clinicalsetting may be a medical, dental, or veterinary office or clinic, ahospital, or any facility or institution that provides treatment topatients.

The pneumatic convective device may be deployed for use with humans,animals, patients, clinicians, practitioners, observers, and so on.

The pneumatic convective device has a pneumatic portion for receivingand distributing at least one stream of pressurized, thermallyconditioned air in a structure for being disposed on, adjacent, or nextto the core of a body.

The embodiments of the invention illustrated and discussed below areinflatable. That is, their structures, flaccid when not in use, tautenwhen receiving a stream of pressurized air. The illustrations portraythese structures in both inflated and uninflated states, with theunderstanding that inflation of these embodiments is not necessary topractice of the invention. Indeed, as consideration of the embodimentswill make clear, inflatability itself is not necessary to practice ofthe invention.

In some embodiments, a clinical garment may be specially designed foruse with a pneumatic convective device. These specially designedclinical garments would function the same as traditional clinicalgarments (i.e., temporarily clothe a patient in a clinical setting whileawaiting and undergoing treatment), but may include a mounting systemfor the pneumatic convective device as well as incorporating slits,openings and the like for access to the pneumatic convective device. Inother embodiments, the pneumatic convective device is an integral partof the clinical garment.

FIGS. 1A-1C illustrate an embodiment of a pneumatic convective devicedisposed for use with a clinical garment according to this invention.The pneumatic convective device 110 may be attached to or received on ahospital gown 112. The device 110 includes two generally rectangularsheets 114 and 116 of material that are sealed together continuously attheir peripheries 118 and intermittently at multiple locations 120within their peripheries. As shown, the sheets 114 and 116 have the samegenerally quadrilateral shape, with an optional U-shaped indentation 122along one edge. At least one opening 128 is provided through the sheet116 (two openings are shown in the figures), and a quadrilateral, hosecard 126 with an inlet port 127 is mounted to the sheet 116 over theopening 128, with the inlet port 127 aligned with the hole 128. The atleast one opening 128 is provided in communication with the spacebetween the sheets 114 and 116.

The inlet port 127 may receive the end of an air hose from which astream of pressurized, thermally-treated air flows, through the opening128, into the space between the sheets 114 and 116. At least one of thesheets 114 and 116 is permeable to air. In this example, only the sheet114 is air permeable, although this is not intended to so limit thescope of the invention. The permeability of the sheet 114 may beprovided by characteristics of the material from which it is formed;alternatively, holes or apertures 132 may be formed in it during theprocess which joins the sheets 114 and 116. Or, permeability of thesheet 114 may result from the characteristics of its formative materialand from formed apertures.

Thus constructed, the sheets 114 and 116 form between themselves apneumatic structure to receive and distribute pressurized air withinitself. At least one permeable member of the device (the sheet 114, forexample) cooperates with the pneumatic structure to emit pressurized airfrom the device. In this regard, one end of an air hose may be receivedthrough an inlet port 127. A stream of pressurized, thermallyconditioned air introduced through the air hose will fill the spacebetween the sheets 114 and 116 and be distributed throughout the space.The pressurized air is emitted from the pneumatic structure through theair permeable sheet 114 and the motion of the emitted air supports heattransfer with a body adjacent, next to or near the pneumatic structure,facing the permeable sheet 114.

As shown in FIG. 1B, the pneumatic convective device 110 is adapted tobe mounted to, received on, supported by or otherwise combined with aclinical garment such as the hospital gown 112. In this embodiment, thegown 112 itself has access openings 142 with flaps 144 through which theinlet ports 127 of the device 110 are accessed. To attach the pneumaticconvective device 110 to the gown 112, double-sided adhesive strips 150may be disposed between the sheet 116 and the inside surface 152 of thegrow 112. The adhesion of the sheet 116 with the surface 152 enables thedevice 110 to be mounted to, received on, supported by or otherwisecombined with the gown 112, with U-shaped indentation 122 adjacent theedge 154 of the gown 112 which receives the neck of a user, the sheet116 facing the inside surface 152, the permeable sheet 114 facing thewearer of the gown 112. In the practice of this invention, the U-shapedindentation 122 is optional, and is not required to practice theinvention.

A variant of the pneumatic convective device of FIGS. 1A-1C isillustrated in FIGS. 1D-1E. In this variant, a portion of the inner gownsurface 152 is incorporated into the structure of the device 110,serving in the role of the sheet 116 in FIGS. 1A-1C. Otherwise, thestructure and operation of the device 110 are as already described.

Alternatively, the device shown in FIGS. 1D-1E may be constructed withan impermeable sheet on the outside of the gown 112, wherein the portionof the gown 112 that includes the inner gown surface 152 would serve asthe permeable sheet.

Refer to FIGS. 1C and 1E for an understanding of how each of theembodiments shown in FIGS. 1A and 1D may be constructed. The sheets 114and 116 may have an identical laminate structure in which a layer (114a, 116 a) of extruded synthetic material is lined with a layer (114 b,1161 b) of non-woven material. If a laminate structure is selected,holes or apertures 132 are formed through both layers 114 a, 114 b ofthe sheet 114. In FIG. 1C, the sheets 114 and 116 are oriented to havethe extruded layers (114 a and 116 a) facing, and the seals 118, 120 areformed by a gluing process or by a heating or ultrasonic process actingthrough one of the layers of non-woven material. In FIG. 1E, the sheet114 may be a laminate structure as described above. The gown 112 is awoven cloth, such as cotton, or a non-woven such asspunbond-meltblown-spunbond material (SMS), and the seals between theportion of its inside surface 152 and the extruded layer of the laminatesheet may be formed by a gluing, a heating, or an ultrasonic process.Examples of non-woven material include any one or more of polyester,cotton, rayon, polypropylene, and wood pulp. Examples of extrudedsynthetic material include polypropylene, polyesters, and polyurethanes.Examples of attachment materials and mechanisms by which the device 110as presented in FIG. 1A can be attached to the gown 112 includetwo-sided adhesive, hook and loop, sewing, snaps, heat, ultrasonic,rivets, and any and all equivalents thereof.

FIGS. 1F-1G show the front of the gown 112. The inlet ports 127 areaccessible from the front of the gown 112. There may be one or moreinlet ports 127 providing access through openings 128. In these cases,it may be desirable to plug an inlet port 127. An inlet port plug 131may be used to close the inlet ports 127 that are not in use with theair hose. Many types of plug may be used to close the inlet ports 127,such as those described in U.S. Pat. No. 5,997,572, which isincorporated herein by this reference.

FIG. 1H illustrates a patient 108 in the standing position wearing thegown 112, which includes the pneumatic convective device 110, asdescribed above. The patient may be in a doctor's office in anout-patient facility, or other suitable location. The gown 112 is shownwith connecting lines that illustrate how it would be attached to thepatient. An end 158 of an air hose 160 is connected to the pneumaticconvective device 110 may received with the hose card 130 to provide astream of pressurized, thermally treated air directed into the device110 through inlet port 127. For the embodiment shown in FIGS. 1A-1C, theflap 144 is lifted, exposing the inlet port 127 and the hose card 130,through an access opening 142. For the embodiment shown in FIGS. 1D-1E,access to the hose card 130 is on the front of the gown 112 (there is noaccess opening). The other end of the air hose 160 is connected to awarming unit 162 that can provide a stream of pressurized, thermallycontrolled air to the device, like the one described in co-pending,concurrently filed patent application “FORCED AIR WRMING UNIT” which isincorporated herein by this reference. The temperature at the hose-end158, prior to the air entering the pneumatic convective device 110, mayrange from ambient to 42° C. The average air temperature delivered tothe patient may be less than this, depending on the gown design. Theairflow at the hose-end 158, prior to the air entering the pneumaticconnective device 110, may be between 5-15 CFM. The pressure inside thepneumatic convective device 110 may range of 0.25 to 0.75 inches H₂O.The warming unit 162 may be mounted on an IV pole 164, as illustrated.

When the stream of pressurized, thermally treated air is provided to thedevice 110, the device 110 tautens and air is emitted through the sheet114, treating the person 108 with thermally controlled air. As can beappreciated with reference to FIG. 1H, with the gown 112 worn by aperson 108, the device 110 is disposed so that the permeable sheet 114faces the person 108 primarily in the region between the person's neckand thighs. Thus when pressurized, thermally treated air is provided tothe device 110, it is distributed within the device, and emitted throughthe sheet 114, focusing or concentrating the emitted air primarily onthe person's upper thorax. Convection will then cause heat transferbetween the emitted, thermally treated air and the person's body core ordiminish heat loss from the person's body to the environment.

The clinical garment described in the above and in below-describedembodiments may be a standard gown, a modified gown or a special purposegown. The gowns may have rear openings, front openings or other openingssuitable openings, such as a head opening in a poncho type gown. Onetype of gown shown in the figures has a rear opening. Referring now toFIGS. 1A-1B, the gown 112 has a slit 170 that extends from the neckportion 154 to a hemline 155. To attach the gown 112 to a patient, thereis a fastening means provided to provide for ease in securing the gownto the patient as well as allowing for ease in adjusting the size of thegown to accommodated various different size wearers. FIG. 1A shows onemethod using hook and eye buttons 171 a, 171 b positioned along opposingsides of the slit 170 a, 170 b that can be brought together and fastenedto hold the gown to the patient. Another method attachment shown is aplurality of strings 172 positioned along opposing sides of the slit 170a, 170 b that can be tied together for hold the gown to the patient.Other methods of attachments include hook and eye elements, double-sidedadhesive, snaps, rivets, and any and all equivalents thereof.

In some embodiments, the clinical garment may include sleeves that aresized and positioned for receiving a patients arms. Two examples ofsuitable sleeves are shown in the figures. In FIGS. 1A-1B, the sleeveportions 175 have slits 176 that run the entire length on the shoulderor top 177. This allows access to the upper body of the patient andallows for opening and closing of the slits 176 in an adjustable fashionusing Velcro buttons, snaps, repositionable adhesive, hook and eyeelements, double-sided adhesive, hook and loop, rivets, and any and allequivalents thereof. The design shown in FIG. 1A also facilitates themanufacturing of the gown 112 in one piece. Another embodiment shown inFIGS. 3A-3B has sleeves 374 are attached to the main or body portion ofthe gown 312 and are not openable.

In FIGS. 2A-2D, an air hose 260 has an end 258, which is in the form ofa nozzle 210 attached to the air hose 260 at an annular junction 212.The nozzle 210 may transition from a tubular rear section 211 through anangle less than 90° to a tubular forward section 214. It is desirablethat the nozzle 210 be provided with a mechanism to releasably couple itwith a hose card of one of the pneumatic convective devices of FIGS.1A-1F. An example of such a mechanism is shown in these figures.Opposing slots 220 are cut longitudinally along the forward section 214of the nozzle, extending to its end 217. An annular flange 216 is formedcircumferentially around the forward section 214 seated over the slots220, back from the end 217. A flexible U-shaped latch 222 comprisingopposing tongs is mounted to the inside of the nozzle 210, extendingfrom the end 217 where the tongs are received in the slots 220, to theend of the rear section 213 in which a groove 223 is cut to receive andseat the spring end of the U-shaped latch 222. Finger pieces 225 mountedon the outsides of the tongs are received in the slots 220, behind theannular flange 216. The tongs have wedge-shaped pieces 227 mounted totheir ends, forward of the annular flange 216. As best seen in FIG. 2A,the tongs of the latch 222 flex together toward the interior of thenozzle, away from the slots 220 in response to pressure applied to thefinger pieces 225. According to the illustration in FIG. 2B, when thepressure is released, the tongs spring back to the annular flange 216.With reference to FIGS. 1H, 2A, and 2B, in operation, the nozzle 210, onthe end of the air hose 260 is brought to an inlet port 127, the tongsare flexed together as in FIG. 2A and the end of the forward section 214is inserted into the inlet port 127 far enough for the annular flange216 to abut the hose card 126. The flexing pressure on the tongs isreleased and the tongs spring back against the annular flange 216. Thehose card is held between the wedge-shaped pieces 227 and the annularflange 216, thereby maintaining the air hose 260 engaged or coupled tothe pneumatic convective device served by the input port 127. The nozzle210 can be disengaged or decoupled from the device by squeezing thetongs of the latch 222 together and removing the forward section 214 ofthe nozzle from the inlet port 127.

Preferably, the diameter of the inlet port is larger than that of thenozzle to allow for easy entry of the nozzle. As the latch is engaged,the nozzle is secured against the inlet port perimeter and abuts theannular flange, thus securing the fit to reduce or eliminate air leakagewhere the inlet port and the nozzle are joined. The nozzle may also beconfigured to swivel to accommodate the diverse range of motion thedevices will experience in various settings.

Another embodiment of an exemplary pneumatic convective device isillustrated in FIGS. 3A-3C. Here, a pneumatic convective device 310according to an embodiment of the invention is attachable to a clinicalgarment or hospital gown 312. The device 310 includes two sheets 314 and316 of material that are sealed together continuously at theirperipheries 318 and intermittently at multiple locations 320 withintheir peripheries. As shown, the sheets 314 and 316 have the samegenerally quadrilateral shape, with an optional U-shaped indentation 322along one edge. At the corners of an opposing edge, the sheets 314 and316 have projections 324 and 326. The seal at the ends 328 and 330 ofthe projections 324 and 326 may be broken, so that at least one openingis provided in communication with the space between the sheets 314 and316. The opening may receive the end of an air hose from which a streamof pressurized, thermally-treated air flows, through the opening, intothe space between the sheets 314 and 316. At least one of the sheets 314and 316 is permeable to air. In this example, only the sheet 314 is airpermeable, although this is not intended to so limit the scope of theinvention. The permeability of the sheet 314 may be provided bycharacteristics of the material from which it is formed; alternatively,holes or apertures 332 may be formed in it during the process whichjoins the sheets 314 and 316. Or, permeability of the sheet 314 mayresult from the characteristics of its formative material and fromformed apertures.

Thus constructed, the sheets 314 and 316 form between themselves apneumatic structure that may receive and distribute pressurized airwithin itself. At least one permeable member of the device (the sheet314, for example) cooperates with the pneumatic structure to emitpressurized air from the device. In this regard, one end of an air hosemay be received through an opening in either of the ends 328 and 330. Astream of pressurized, thermally conditioned air introduced through theair hose will fill the space between the sheets 314 and 316 and bedistributed throughout the space. The pressurized air is emitted fromthe pneumatic structure through the air permeable sheet 314 and themotion of the emitted air supports heat transfer with a body adjacent,next to or near the pneumatic structure, facing the permeable sheet 314.

As shown in FIGS. 3B, 3H, and 3J, the pneumatic convective device 310 isadapted to be mounted to, received on, supported by or otherwisecombined with the hospital gown 312. In this embodiment, the gown 312itself has slits 342 and 344 through which the ends 328 and 330 of thedevice 310 are received. In addition, double-sided adhesive strips 350are disposed between the sheet 316 and the inside surface 352 of thegown 312. The interconnection of the ends 324, 326 with the slits 342,344 and the adhesion of the sheet 316 with the surface 352 enable thedevice 310 to be mounted to, received on, supported by or otherwisecombined with the gown 312, with the U-shaped indentation 322 adjacentthe edge 354 of the gown 312 which receives the neck of a user, thesheet 316 facing the inside surface 352, the permeable sheet 314 facingthe wearer of the gown 312, and the ends 324, 326 extending through theoutside surface of the gown 312. (Note that the U-shaped indentation 322is optional, and is not required to practice the invention.)

As illustrated in FIGS. 3G, 3I, and 3K, with the device 310 mounted tothe gown 312, the seal between the peripheries of the sheets 314, 316has been breached at the end 330, providing at least one opening throughwhich the end 358 of an air hose 360 may be received to provide a streamof pressurized, thermally treated air directed into the device 310. Theat least one opening can also be provided through the end 328. Theconnection of the end 358 with the end 330 is on the outside of the gown312, as best seen in FIGS. 3G and 3K. When the stream of pressurized,thermally treated air is provided to the device 310, the device 310tautens as shown in FIG. 3I, and air is emitted through the sheet 314.As can be appreciated with reference to FIG. 3K, with the gown worn by aperson, the device 310, mounted to the gown 312 as described, isdisposed so that the permeable sheet 314 faces the person primarily inthe region between the person's neck and thighs. Thus when pressurized,thermally treated air is provided to the device 310, it is distributedwithin the device, and emitted through the sheet 314, focusing orconcentrating the emitted air primarily on the person's body core.Convection will then cause heat transfer between the emitted, thermallytreated air and the person.

A pneumatic convective device similar to that illustrated in FIGS. 3A-3Cis illustrated in FIGS. 3D-3F. In this embodiment, a portion of theinner gown surface 352 is incorporated into the structure of the device310, serving in the role of the sheet 316 in FIGS. 3A-3C. Otherwise, thestructure and operation of the device 310 are as already described.

Alternatively, the device shown in FIGS. 3D-3F could be constructed withan impermeable sheet on the outside of the gown 312, wherein the portionof the gown 312 that includes the inner gown surface 352 would serve asthe permeable sheet. Also, in the case of a gown opening in the front,the pneumatic convective device of these figures could be adapted formounting to the back of the gown.

Refer to FIGS. 3C and 3F for an understanding of how each of theembodiments shown in FIGS. 3A and 3D may be constructed. The sheets 314and 316 may have an identical laminate structure in which a layer (314a, 316 a) of extruded synthetic material is lined with a layer (314 b,316 b) of non-woven material. If a laminate structure is selected, holesor apertures 332 are formed through both layers 314 a, 314 b of thesheet 314. In FIG. 3C, the sheets 314 and 316 are oriented to have theextruded layers (314 a and 316 a) facing, and the seals 318, 320 areformed by a gluing process or by a heating or ultrasonic process actingthrough one of the layers of non-woven material. In FIG. 3F, the sheet314 may be a laminate structure as described above. The gown 312 is awoven cloth, such as cotton, or a non-woven such asspunbond-meltblown-spunbond material (SMS), and the seals between theportion of its inside surface 352 and the extruded layer of the laminatesheet may be formed by a gluing, a heating, or an ultrasonic process.Examples of non-woven material include any one or of polyester, cotton,rayon, polypropylene, and wood pulp. Examples of extruded syntheticmaterial include polypropylene, polyesters, and polyurethanes. Examplesof attachment materials and mechanisms by which the device 310 aspresented in FIG. 3A can be attached to the gown 312 include two-sidedadhesive, hook and loop, sewing, snaps, heat, ultrasonic, rivets, andany and all equivalents thereof.

In FIGS. 4A-4C, the air hose 460 has an end 458, which is in the form ofa nozzle 410 attached to the air hose 460 at an annular junction 412.The nozzle 410 may be cylindrical or frusto-conical in shape. It isdesirable that the nozzle 410 be provided with a mechanism to releasablycouple it with a sleeve of one of the pneumatic convective devices ofFIGS. 3A-3F and 6A-6I. An example of such a mechanism is shown in thesefigures. In this example, the nozzle 410 has an elongate longitudinalgroove 414. A latch 416 is mounted to the nozzle 410 on a pivot pin 419.The latch 416 is able to pivot on the pin 419 toward and away from thegroove 414. The latch 416 has a bar 418 that may be snapped into thegroove 414 to retain the latch in a latching engagement with the groove414. The latch may be pulled away from the groove 414 to unsnap the bar418 therefrom. The snapping engagement of the bar 418 and the groove 414permits the sleeve formed in the projection 426 (or in the Y stem 620shown in FIGS. 6A-6I) to be held by or to the nozzle 410 in a releasablycoupled engagement therewith while a stream of pressurized, thermallytreated air is provided to the pneumatic convective device of which thesleeve is an element. The sleeve and nozzle may be decoupled andseparated when the bar 418 is unsnapped from the groove 414.

Preferably, the diameter of the sleeve is larger than that of the nozzleto allow for easy entry of the nozzle. As the latch is engaged, itgathers the excess material of the sleeve, and pulls it into the groove,thus securing the fit to reduce or eliminate air leakage where thesleeve and the nozzle are joined. The nozzle may also be configured toswivel to accommodate the diverse range of motion the devices willexperience in various settings.

The respective parts of the air hose end shown in FIGS. 4A-4C may bemolded from plastic, assembled by bonding, and then attached to the endof an air hose by conventional means.

FIGS. 5A-5C illustrate complementary adaptations of a pneumaticconvective device according to FIG. 3A-3F and the end of an air hose. Inthese figures, a pneumatic convective device 510, with or withoutprojections, and without an indentation, is disposed on a gown 512, withthe permeable sheet 14 facing inwardly of the gown 512. An opening 568into the pneumatic structure is provided between the upper edge 554 ofthe gown 512 and the upper edge 568 of the sheet 514. This opening 568provides air flow access into the pneumatic structure. The air hose 560has a crooked end 558 with a bent portion 560, the end 561 of which maybe received in the opening 568, with the inner part of the bent portion560 supported on the upper edge 554 of the gown 512. In operation, astream of pressurized, thermally treated air flows through the hose 560,into the crooked end 558, the bent portion 560, and the end 561 into thepneumatic convective device 510. The air hose end 558 may be molded fromplastic.

FIGS. 6A-6I illustrate another exemplary pneumatic convective devicewhich embodies the invention. FIGS. 6A, 6B and 6D illustrate the device680, after it has been fabricated, with FIG. 6A showing an exploded viewof the device and FIG. 6B showing an assembled view of the device. Thepneumatic convective device 680 may be made by joining two sheets ofmaterial 690 and 692. Preferably, at least one of the sheets 690 and 692is permeable to air; in this example, the sheet 692 is air-permeable,this being represented by apertures 693 that open through the sheet 692.The two sheets 690 and 692 are sealed together continuously at theirrespective peripheries 612, in a non-inflatable region 613 extendinginwardly from one edge in the direction of an opposing edge, andintermittently at a plurality of locations 614 in a distribution region617 bounded by the non-inflatable region 613, the opposing edge, and thesides of the sheets 690 and 692. An opening 615 is provided through thetwo sheets 690 and 692 in the non-inflatable region 613. A generallyY-shaped contoured opening 619 is provided through both sheets 690 and692 in the region 617. The region 617 is sealed from the opening 619 bythe continuous seal 618. As thus constructed, the device 680 includesthe non-inflatable region 613, the region 617, and a Y-shaped region 621defined by the contoured opening 619. The Y-shaped region has a stem 620and transitions to two branches 620 a and 620 b through which itcommunicates with the distribution region 617.

FIGS. 6C and 6F show the device 680 deployed for use. As illustrated,the opening 615 receives the head of a user so that the device 680 isdisposed on the neck and shoulders of the user much like a Mae West lifejacket, with the sheet 692 facing toward, and the sheet 690 away from,the user. In this disposition, the non-inflatable region 613 hangs overthe user's shoulders, toward the user's back, while the distributionregion 617 and the Y-shaped region 621 are disposed adjacent, or near tothe user's chest, with the stem 620 pointing toward the user's waist.FIG. 6H shows the hospital gown received over the device 680, so thatthe distribution region 617 is disposed between the user and the gown612, with the Y-shaped region 621 extending over the edge 654 anddisposed on the outside of the gown 612.

In FIG. 6C, the end 622 of the stem 620 is opened; in FIG. 6G, the end658 of the air hose 660 is received in the opened end 622 and provides astream of pressurized, thermally-conditioned air. The pressurized airflows through the stem 620 into the branches 620 a and 620 b of theY-shaped region 621 whence it is distributed through and inflates thepneumatic structure of the distribution region 617. The air is emittedfrom the distribution region 617 through the permeable sheet 692 towardthe body core of the user. The figure shows the inflatable, comfortablehose connection portion of the device to be at the neck area, however itshould be noted that it could be alternatively be located at the arm,back, shoulder or lower hem areas.

Refer now to FIGS. 6D and 61. When the device 680 is disposed withrespect to the gown 612 as shown in FIG. 6H and pressurized air isprovided as in FIG. 6G, the air is distributed through the regions 621and 617 and is emitted toward the body core of the user through thepermeable sheet 692.

The sheet 692 may have the structure described above for the sheet 614,while the sheet 690 may have the structure described above for the sheet616.

One advantage of the embodiments thus far disclosed is that thepneumatic convective devices may be provided to the user in bulkfashion, such as on a roll or in a dispenser box. For example, thedevices provided on a roll dispenser may have perforated linesseparating each device. Users may simply select a new device forapplication in the field, say in the patient's dressing room or at thepatient's care site. Further, as in the case of the embodiment shown inFIG. 3A, the patient or clinician may select the pneumatic device from aroll and insert it into a gown as desired. In this way the gowns may belaundered and reused and each pneumatic device disposed of after use.This roll dispenser will allow for more cost-effective inventory storageand ease of accessibility.

FIGS. 7A-7F illustrate complementary adaptations of a pneumaticconvective device according to FIG. 6A-6C and the end of an air hose. Inthe pneumatic convective device 780 which is shown in FIG. 7D, the stem720 is shortened, and the seal 718 terminates in an open configurationnear the end 722, which is defined by two spaced-apart ends 718 a and718 b of the seal 718. As best seen in FIGS. 7E and 7F, a third seal 718c between the sheets 790 and 792 is disposed between the ends 718 a and718 b, and extends from the opening 715 toward the end 722. These sealsdivide the stem 720 into the respective branches 720 a and 720 b of theY-shaped region 721. Each branch is in communication with thedistribution region 717. A nozzle 765 formed as a manifold is adapted tobe received in the end 722 and to provide a plurality of separatestreams of pressurized, thermally treated air into the device 780. Thenozzle 765 has a plenum 780, and two further plenums 784 and 786 thatare in communication with the plenum 780. The manifold nature of thenozzle lies in its ability to accept a stream of pressurized, thermallytreated air through the plenum 780 and to split or divide the streaminto two streams of pressurized, thermally treated air such that each ofthe streams is provided to a respective one of the branches 720 a and720 b. The specific nozzle construction that is shown in these figuresis meant to be illustrative of but one embodiment of a manifold nozzle,it being understood that other equivalent constructions will occur tothe skilled artisan who is put in possession of these teachings.

Each of the plenums is illustrated in FIGS. 7A-7C as a cylindricalsection; although this is a preferred shape, it is not the only one thatcan be used. The plenum 780 has a connecting ring 770 mounted at one ofits ends for seating on the end of an air hose. A cap 781 closes theother end of the plenum 780. One end of the plenum 784 has a cap 783mounted to it; the other end 785 is open and in the shape of an offsetpoint. Similarly, one end of the plenum 786 has a cap 785 mounted to it;the other end 789 is open and in the shape of an offset point. Theplenum 784 is mounted, joined to, or formed integrally with the plenum780 near the cap 781 such that the cap 783 adjoins and partiallyoverlaps the cap 781. Similarly, the plenum 786 is mounted, joined to,or formed integrally with the plenum 780 near the cap 781 such that thecap 785 adjoins and partially overlaps the cap 781. As best seen in FIG.7C, the nozzle 765 opens from the connecting ring 770, through theplenum 780, to, through and out the respective ends of each of theplenums 784, 786. As shown schematically in FIGS. 7A and 7E, thisconstruction divides an input stream of air 794 into two streams 796 and798.

The manifold nozzle 765 is received in the stem 720 through the end 722,with the plenum ends 788 and 789 positioned in the branches 720 a and720 b, respectively. The manifold nozzle 765 is retained in thisposition by a pommel 790 which engages an opening 791 formed in the stem720. Thus disposed, the manifold nozzle 765 provides a stream of air tothe Y-shaped portion 721 of the pneumatic convective device 780 by wayof the plenum 780, which is adapted by the connecting ring 770 forseating on the end of an air hose to receive a stream of pressurized airfrom the air hose. The two plenums 784 and 786 are disposed against theplenum 780 in a spaced-apart array corresponding to branches 720 a and720 b of the Y-shaped portion 721. In this regard, the spaced-apartarray illustrated has the two plenums 784 and 786 disposed in parallelat diametrically opposed locations on respective sides of the plenum780. This is not meant to constrain the spaced apart array to just sucha configuration. Indeed, the plenums 784 and 786 may be disposed todiverge at an angle such as an angle at which the branches 720 a and 720b diverge in the Y-shaped region 720. Each of the two plenums 784 and786 has an opening in communication with the plenum 780 for emitting arespective stream of pressurized air into a respective branch of theY-shaped region in response to the stream of pressurized air received bythe plenum 780.

The manifold nozzle may be assembled by joining separate pieces, eachmolded from plastic, or the entire nozzle may be molded from plastic asa unitary device and mounted conventionally to an end of an air hose.

In a case where an air hose is coupled to a pneumatic convective devicethrough the end of a projection, such as in the first two sets of FIGS.(3A-3F and 6A-6I) the projection is typically in the form of a sleeve.This can be seen clearly in FIGS. 3G and 6D. In such cases, the air hoseend must be adapted for use with a sleeve. An objective of such usewould be to releasably couple the air hose end to the sleeve in such amanner that the air hose end remains disposed within the sleeve in orderto deliver a stream of pressurized, thermally treated air into thepneumatic convective device while the device is in use, while providingthe ability to be simply decoupled or released from the sleeve when theuse is ended. One example of a mechanism that meets this objective isillustrated in FIGS. 4A-4C.

The embodiments that are illustrated and described above are meant to berepresentative, and not limiting, of our invention. Other variations andembodiments will be apparent to those skilled in the art upon readingthis description. For example, the illustrations and description show apneumatic convective device disposed on or at the front of a clinicalgarment for convectively warming the chest of a person. The pneumaticconvective device could also be mounted to or disposed at the back orsides of the garment, or may be adapted, sized, or constructed to extendalong more or less of the thorax than shown in the illustratedembodiments of this invention.

1. A mechanism for releasably coupling an end of an air hose to a sleeveof a pneumatic convective device, comprising: a nozzle; a groove in thenozzle; a latch for pivoting toward and away from the groove; and a baron the latch for releasably engaging the groove.